Loading clinical trials...

Not Yet RecruitingNANCT06985641

Khanya Ekhaya: A Home-Based Intervention

Mental health conditions, such as depression, anxiety, and harmful alcohol use are prevalent among people with chronic diseases, including HIV, and contribute to poor engagement in care. There is a ne...

Lead sponsor: University of Maryland, College Park•1 locations•View source on ClinicalTrials.gov

Clareo plain-language summary

What this study is about

Generating AI summary...

Save this trial guide to your notes

Keep your clinical trial research organized — questions to ask, what to expect, and key details.

Contacts

Jessica F Magidson, PhD

CONTACT

301-405-5095 [email protected]

Abigail C Hines, MPH

CONTACT

[email protected]

Sponsors

Lead Sponsor

University of Maryland, College Park

Collaborators

Medical Research Council, South Africa
Fogarty International Center of the National Institute of Health
Curtin University

The overall aim of this 3-phase study (the third phase being the clinical trial) is to develop a feasible mental health intervention for CHW delivery during home-based care for people with chronic conditions, including HIV. Investigators will use an existing cadre of CHWs conducting home visits, highlighting the potential for sustainability. Aim 1: To explore barriers and facilitators to implementing a home-based, CHW-delivered intervention for mental health concerns (depression, anxiety, harmful alcohol use) "Khanya-Ekhaya". Guided by the Consolidated Framework for Implementation Research (CFIR), investigators will accomplish this aim by conducting individual semi-structured interviews with CHWs and other key stakeholders, including CHW supervisors, policymakers, and organizational leaders and patients with mental health problems. Key domains of the interviews include: (a) appropriateness of providing integrated home-based care for mental health among people newly initiating or re-initiating HIV services after ≥3 months; (b) barriers and facilitators to implementing a CHW-delivered intervention for mental health and HIV care engagement in patients' homes, including how to promote feasibility within CHWs' existing roles; (c) training and supervision needs of CHWs, including how to manage risk and support referrals; and (d) adapting existing evidence-based intervention components developed by the research team (problem solving, motivational interviewing, behavioral activation, mindfulness) for CHW home-delivery. Aim 2: To adapt with patients and CHWs a home-based, intervention to improve mental health symptoms and HIV outcomes "Khanya-Ekhaya". Investigators will adapt a home-based CHW intervention ("Khanya-Ekhaya" or "Khanya at home") to address mental health symptoms and improve HIV care engagement based on our formative clinic-based work and training CHWs in reducing mental health stigma refined based on Aim 1 feedback. Adapting the intervention components from clinic-based delivery to CHW home-based delivery will be heavily guided by qualitative analysis in Aim 1. Aim 3 (Clinical Trial). To evaluate the implementation and preliminary effectiveness of a home-based CHW intervention "Khanya-Ekhaya" to reduce mental health symptoms and improve engagement in HIV care. In a pilot Type 1 hybrid effectiveness-implementation trial, investigators will evaluate the effectiveness and implementation of the Khanya-Ekhaya home-delivered CHW intervention. This trial will demonstrate successful training of CHWs, reaching patients of interest, and collecting primary outcomes to inform future work.

Related studies

RECRUITINGNA

The Effects of Chiropractic Care on Inflammation and Quality of Life in People Living With HIV

NCT07466836 · Human Immunodeficiency Virus (HIV)

RECRUITINGNA

Stress and Pain in People Living With HIV

NCT06784908 · HIV, Depression, and more

RECRUITINGPhase 2

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

NCT06749054 · HIV-1-infection

RECRUITING

Thinking and Memory Problems in People With HIV

NCT01875588 · HIV Positive

RECRUITINGNA

Virtual Patient Groups for Sarcoidosis Associated Fatigue

NCT07073963 · Sarcoidosis, Fatigue, and more

View all related studies →

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 22, 2025Terms

Trial snapshot

StatusNOT_YET_RECRUITING

PhaseNA

Enrollment119

Start dateSep 2025

Last updatedMay 22, 2025

Condition

HIV HIV Antiretroviral Therapy (ART) Adherence Mental Health Substance Use Disorders Stigma+5 more

Locations shown

South African Medical Research Council - Delft Office

Cape Town, Western Cape

For caregivers

Use Clareo to keep notes, questions, trial details, and next steps organized before and after appointments.

Start free trial →

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions